FDA Law Blog

NOVEMBER 27, 2023

17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. Then, earlier this year, in April 2023, Gree USA, Inc., The government charged these individuals with conspiracy (18 U.S.C. §

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FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. launch would be in early 2024.

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FDA Law Blog

SEPTEMBER 14, 2021

PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. the amount Part D plans pay pharmacies for the drugs).

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